A Phase 4/3, Open-label, Single-arm, Multicenter Study To Describe The Safety And Immunogenicity Of 13-valent Pneumococcal Conjugate Vaccine In Adults 50 To 65 Years Of Age And In Children 6 To 17 Years Of Age In India

Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) Within 1 Month After 13vPnC Vaccination

时间窗: Within 1 month after 13vPnC vaccination

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 1 month after last dose that were absent before treatment or that worsened relative to pre-treatment state.

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) Before 13vPnC Vaccination

时间窗: Before 13vPnC vaccination

Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50 percent (%). For each serotype, GMTs were calculated using the logarithmically transformed assay results. Confidence intervals (CIs) for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.

Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After 13vPnC Vaccination

时间窗: 1 month after 13vPnC vaccination

Antibody-mediated opsonophagocytic activity against each of the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were measured using a quantitative functional OPA assay. OPA titers were expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. For each serotype, GMTs were calculated using the logarithmically transformed assay results. CIs for GMTs were back transformations of a CI based on the Student t distribution for the mean of the logarithmically transformed assay results. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.

Geometric Mean Fold Rise (GMFR) for Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) From Before 13vPnC Vaccination to 1 Month After 13vPnC Vaccination

时间窗: Before 13vPnC vaccination, 1 month after 13vPnC vaccination

GMFRs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from before 13vPnC vaccination to 1 month after 13vPnC vaccination were computed using the logarithmically transformed assay results. CIs for GMFRs were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before and after vaccination blood draws. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.

Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) Before 13vPnC Vaccination

时间窗: Before 13vPnC vaccination

Percentage of participants achieving serotype-specific pneumococcal OPA titer \>=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.

Percentage of Participants With Opsonophagocytic Activity (OPA) Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After 13vPnC Vaccination

时间窗: 1 month after 13vPnC vaccination

Percentage of participants achieving serotype-specific pneumococcal OPA titer \>=LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are presented. Exact 2-sided CIs for the observed proportion of participants were calculated using Clopper and Pearson method. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210 (for adult participants); Pn7F, 113 (for pediatric participants) Pn09V, 345 (for adult participants); Pn09V, 141 (for pediatric participants); Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. Here, number of participants analyzed (N) signifies participants evaluable for this outcome measure.